Moderate Intensity Functional Training as Adjuvant Treatment in Patients With Peripheral Arterial Disease
Vascular-Fit: Efficacy of an In-hospital Physical Exercise Program on Functional Capacity and Quality of Life in Patients With Peripheral Artery Disease
1 other identifier
interventional
15
1 country
1
Brief Summary
Traditional aerobic training and muscle resistance ('strength') training have been shown to be effective for improving functional and health-related quality of life (HRQoL) outcomes in peripheral arterial disease (PAD). However, the transfer of the current resistance exercise modes proposed to other activities of daily living (ADLs) is questionable. Moderate intensity functional training (MIFT) has emerged with the aim of achieving cardiovascular and neuromuscular adaptations simultaneously with functional exercises typical of ADLs. The effect of MIFT in patients with PAD is not yet known. Our purpose is to verify the influence of the combination of intermittent treadmill walking exercise with MIFT compared with intermittent treadmill walking exercise on functional capacity, HRQoL, biochemical and hemodynamic parameters in patients with PAD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJanuary 11, 2024
January 1, 2024
1.4 years
November 8, 2021
January 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Six-Minute Walk Test
Changes in maximum walking distance (MWD) and claudication onset distance (COD).
0 weeks, 6 weeks and 12 weeks.
Moderate intensity functional training Test
Changes in number of rounds/repetitions and total workload.
0 weeks, 6 weeks and 12 weeks.
Short Form-36 Health Survey (SF-36)
Changes in the eight domains of health status.
0 weeks, 6 weeks and 12 weeks.
Vascular Quality of Life Questionnaire-6 (VascuQol-6)
Changes in total punctuation of questionnaire.
0 weeks, 6 weeks and 12 weeks.
Secondary Outcomes (10)
Biochemical analysis
0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
0 weeks, 6 weeks and 12 weeks.
Biochemical analysis
0 weeks, 6 weeks and 12 weeks.
- +5 more secondary outcomes
Study Arms (2)
Intermittent treadmill walking exercise and moderate intensity functional training
EXPERIMENTALSubjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise and moderate intensity functional training.
Intermittent treadmill walking exercise
ACTIVE COMPARATORSubjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise.
Interventions
Subjects will perform a 12-week supervised exercise therapy program based on intermittent treadmill walking exercise (15-30 min.) and moderate intensity functional training (MIFT) (15 min.). In intermittent treadmill walking exercise, the speed and incline of treadmill will be adjusted that patients achieve moderate claudication pain in the time interval between 3 and 5 min. In MIFT, subjects must complete in 15 min. the highest number of repetitions / rounds possible (AMRAP) to a circuit composed of 6 global functional exercises from which they performed 10 repetitions with a rating of perceived exertion (RPE) of 5-7 on a 1 to 10 scale in each exercise.
Subjects will perform a 12-week supervised exercise therapy program based on intermittent treadmill walking exercise (30-45 min.). In intermittent treadmill walking exercise, the speed and incline of treadmill will be adjusted that patients achieve moderate claudication pain in the time interval between 3 and 5 min.
Eligibility Criteria
You may qualify if:
- Subjects with PAD in grade IIa (Leriche-Fontaine Classification).
You may not qualify if:
- Subjects with dementia.
- Institutionalized Subjects in social health centers.
- Subjects with recent major surgery in the last year or lower limb amputations.
- Subjects with revascularization surgery of the lower extremities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European University Miguel of Cervantes
Valladolid, 47012, Spain
Related Publications (1)
Penin-Grandes S, Lopez-Ortiz S, de la Fuente Gomez M, Pinto-Fraga J, Lista S, Maroto-Izquierdo S, Lucia A, Del Rio Sola ML, Martin-Hernandez J, Santos-Lozano A. Move Better, Live Better: A Novel Supervised Combined Training for Peripheral Arterial Disease: A Quasi-experimental Approach. Am J Phys Med Rehabil. 2025 Sep 1;104(9):771-779. doi: 10.1097/PHM.0000000000002706. Epub 2025 Jan 6.
PMID: 39792377DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2021
First Posted
November 19, 2021
Study Start
November 19, 2021
Primary Completion
April 30, 2023
Study Completion
June 30, 2023
Last Updated
January 11, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share